The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma

Completed

• Conditions: Bone Fractures; Multiple Trauma; Delirium

• Registration Number: NCT02086981
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief Summary

Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.

Detailed Description

The aging of population as well as the increased life expectancy put progressively urgent demands about the adequacy of the level of care provided in a hospital environment to ensure clinical pathways tailored on the needs of each individual patient. On the other hand, the gradual evolution of Health Care systems to care for the acute, with increasing levels of specialization often technologically driven, cannot and must not neglect these aspects of personalization of care protecting the elderly "frail" patient, because of its intrinsic characteristics. In such a context, evaluation of frailty undertakes not only the meaning of prevention and promotion of quality of life but it takes in account important issues for patient's safety and the economic weight it entails. Delirium (acute confusional state) is a complex syndrome which frequently occurs in the elderly hospitalized population. Development of Delirium is associated with negative outcomes such as a longer hospital stay, a higher rate of complications, cognitive and functional decline, loss of independence, institutionalization, and, ultimately, death. For skilled healthcare professionals, on the other hand, it represents a challenging condition because a prompt and accurate diagnosis with the introduction of all those prevention and non-pharmacological measures may reduce the incidence, severity and/or duration of Delirium and improve functional recovery. Therefore the meaning of conducting such an observational study is also to provide evidence of patients' needs and address the on-ground educational aspect for healthcare professionals in a daily practice. The purposes of the study are to determine the incidence and prevalence (before and after surgery) of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase as well as to determine the risk factors for developing such a condition. Secondary objectives are mean hospital stay, rates of complications as well as in-hospital mortality and at 1, 3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 months follow-up.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-22
• Study First Submitted QC: 2014-03-09
• Study First Posted: 2014-03-14
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-25
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 672

Inclusion Criteria

• Patients with any medical condition with an age of 65 years and older

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Exclusion Criteria

• Impossibility to give an informed consent; refusal

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Delirium, its association with risk factors and their prognostic value	At hospital admission	Patients are evaluated on admission with: * IqCode; * Katz Index of Independence in Activities of Daily Living (ADL); * The Lawton Instrumental Activities of Daily Living (IADL) Scale; * The Barthel Index for Mobility; * The Confusion Assessment Method (CAM); * The 4AT Scale; * Presence of Risk Factors
Incidence of Delirium, its association with risk factors and their prognostic value	After surgery and for the next 48 hours	Detection of any change in clinical condition. Patients are evaluated with: * The Confusion Assessment Method (CAM); * The 4AT Scale

Secondary Outcome Measures

Name	Time	Method
Mortality rates	At 1,3 and 12 months follow-up
Changes in functional capabilities	At 1, 3 and 12 months follow-up	Patients are evaluated with: * Katz Index of Independence in Activities of Daily Living (ADL); * The Lawton Instrumental Activities of Daily Living (IADL) Scale; * The Barthel Index for Mobility
Mean Hospital Stay	In-Hospital
Clinical Complications	In-Hospital

Trial Locations

Locations (1)

C.T.O. Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Florence, Italy